July 9, 2013 ~“Our job together is to figure out the facts. Trust is a sacred and powerful thing. Although a corporation may be doing good work, if you find they failed in warning, making and manufacturing this device, you must hold them accountable.”
That was the opening statement from attorney Henry Garrard who represents Donna and Dan Cisson in the first federal trial over transvaginal mesh.
Donna Cisson, 55, was implanted with the Bard Avaulta Plus BioSynthetic Support System to treat prolapse in May 2009. Her Ob/Gyn Dr. Brian Raybon had determined she had a stage three out of four rectocele, or prolapse of the rectum into the vagina. The surgery took place in Toccoa, Georgia at the Stephens Co. Hospital, a town where Donna worked as a public health nurse.
Hers is the first of nearly 4,000 cases consolidated in the same federal court naming C.R. Bard, the manufacturer of Avaulta line of mesh products, along with 20,000 other product liability cases naming five other mesh manufacturers.
The jury of five women and three men selected Monday listened to the opening arguments by Garrard of Blasingame, Burch, Garrard & Ashley P.C. and Lori Cohen of Greenberg Traurig of Atlanta.
According to Law 360 when Cohen walks into a courtroom, she owns it. “Her ability to befriend everyone, from the bailiff to the opposition’s witnesses, coupled with her focus on out-preparing the competition, have led to 55 straight trial victories and landed her a spot among Law360’s Top Female Trial Attorneys.”
Cohen made herself known during Monday’s jury selection, smiling, greeting and shaking hands with almost everyone on the defense half of the courtroom.
During his opening, Garrard referred to the MSDS, Materials Safety Data Sheet, which was contained in released court documents. Managers at Bard’s Davol unit used a resin made by Chevron Phillips to make mesh used for pelvic placement and hernias. Chevron had registered a warning that the raw Marlex PP mesh resin was not to be used in medical devices permanently implanted in human beings. Emails between Bard executives had warned not to let Chevron know and said it “will likely not be interested in a medical application due to product liability concerns.”
Garrard told jurors no one at Bard contacted Chevron Phillips to figure out what the medical problems could result from the use of the plastic in medical devices.
“They’ll say it was because Phillips was worried about lawsuits. Maybe Bard should too,” he added.
Garrard told the jury evidence will show Bard knew of the high risk of erosion and scar formation in 2003. The company took snips of mesh to test on four sheep and 36 rats, but he said, “You can’t put it in rats and sheep like it’s a person and you can’t test to see what happens two years down the road after implantation.”
“Bard will tell you they brought doctors into a hotel ballroom and brought in a cadaver to show doctors how to put it in, yet it can’t tell them how to take it out in a cadaver. A cadaver doesn’t have blood flow like a human. They didn’t tell the doctors what to do if it goes bad.”
Garrard said that Ms. Cisson had one mesh removal surgery with Dr. Raybon then a second with Dr. Miklos in Atlanta. He had to leave the long arms of the Avaulta behind.
“The arms are like rebar and concrete. You can’t get them out. She’s got to worry about them forever. They’re there.” he told the jury. And the company didn’t know how much its Avaulta mesh would shrink after it was implanted, critical because two incisions in the buttocks would serve as both the entry and exit point for the four arms of mesh.
Bard had thousands of pages in binders that filled five long wooden pews in the courtroom. They were lined up on the bench so no one could sit. Below the bench were white boxes filled with legal documents.
Bard will tell you she consented to the procedure Garrard told the jury predicting the defense strategy. “She didn’t consent to a defective product and the negligence of the defendant.”
During a deposition with the president of Bard Urological, Mark Downey, was asked about a survey given to doctors about the importance of reducing complications. He was asked what he had done to reduce complications.
“I didn’t do anything personally, this survey was to give feedback to department heads. It wasn’t my responsibility to reduce complications,” he reportedly said.
Lori Cohen was next to address the jury. Dressed in a purple suit with platinum swept back hair, Cohen was animated and friendly. She created a picture of the evolution of surgical transvaginal mesh that runs contrary to the image of mesh manufacturers dispatching a legion of sales rep to push doctors to start using polypropylene (PP) mesh in the late 1990’s and early 2000.
Instead she said, “The doctors decided they needed help and came to Bard to find a solution.”
Cohen said there is a difference between the raw material and the final medical device, making reference to the MSDS. “Polypropylene is a time-tested safe material,” she said referring to its use for 50 years in all types of surgeries.
Cohen insisted the implanting physician Dr. Raybon did know about the complications associated with polypropylene mesh and Ms. Cisson knew too as evidence by her signature on an informed consent form.
Besides, she added, Ms. Cisson received an Align mesh used for her incontinence, implanted at the same time as the Bard Avaulta rectocele mesh. The Align remains in her without complications, Cohen said.
Saying that thousands of women suffer from prolapse doctors sought a mesh solution complete with arms.
“The arms are providing support. Thank goodness for the arms,” Cohen said.
Calling mesh surgeries 95% successful in the literature, Cohen said mesh provided the most success in all pelvic floor surgeries. However, all have risks, she warned, especially in patients with a compromised health.
Cohen went on to list Donna Cisson’s health problems including incontinence, a traumatic birth with forceps, which created scar tissue, a hysterectomy, depression, thyroid cancer, a gallbladder procedure, a rectocele that was not discovered until it was grade 3 out of 4, spinal stenosis, joint disease, pain in her lower back and right hip and knee pain, some of which could be attributed to her spinal problems. And though she hesitated to mention it, Cohen added that Cisson’s obesity contributed to her problems.
The numerous surgeries she had, a hysterectomy, mesh implant, two mesh removals, an episiotomy all led to scarring and “scarring can lead to pain,” Cohen said.
Dr. Brian Raybon was the first witness. He implanted Donna Cisson’s Avaulta mesh in May 2009 in Toccoa, Georgia where he is a board certified Obstetrician and Gynecologist. Dr. Raybon was also what’s known as a “preceptor.” Manufacturers choose doctors, likely young and upcoming, to train to become teachers of other doctors. Often the preceptor would train others during a weekend cadaver session. Dr. Raybon said on a good year he could earn an addition $60-thousand to $80-thousand a year as a preceptor.
Dr. Raybon explained that Bard had created two generations of Avaulta mesh. The first was a pre-cut mesh with arms that had a “water loving coating” made of collagen. The second generation was larger PP mesh made with pigskin. The Align sling, also implanted in Ms. Cisson in 2009 to treat incontinence does have the collagen coating. Dr. Raybon explained through an animation the surgery involved the use of trocars or instruments to thread the mesh through two incisions in the buttocks. Four arms of the mesh would eventually exit the two incisions.
The jurors stared at screens provided them and appeared to take notes which is allowed in this trial.
During a May 2009 pre-op visit, Ms Cisson signed a consent form outlining the possible complications of her upcoming surgery – a risk of painful sex, erosion, infection or rejection, colostomy, deep vein thrombosis, embolism, fistula, neuropathic pain, bladder and rectal pain. Shortly after the procedure she returned suffering pain, drainage and what Dr. Raybon felt was an adhesion or scar band that had formed in response to the surgery and mesh. He described it as “tight like a banjo string.”
During the opening arguments Lori Cohen had suggested that Cisson’s episiotomy had resulted in the formation of scar tissue. “There was a scar from the previous childbirth, but nothing like a banjo string,” the doctor said.
Dr. Raybon said he had understood from the company that the mesh had a scar and contraction rate of about 10-15%. “Did anyone tell you Bard reported information on mesh shrinkage at 30-50%?” asked Jim Matthews, a plaintiff attorney.
The doctor said that is information he would have liked to know, especially since he was putting his name on the line in promoting the Bard products. He also said he did not know the porcine mesh had a higher rejection rate and that the resin manufacturer had warned not to use the raw material for medical devices.
“When I saw that I was flabbergasted to see this. It really bothered me,” he said. “I would not have used it.”
On cross examination, Lori Cohen asked Dr. Raybon if he understood no one from Bard could inform him since litigation was underway.
She pointed out that Chevron Phillips included no warning in its materials sheet in 2003. She then established how much money he had made as the first U.S. doctor to use the Avaulta mesh kits. Cohen continued asking how much Dr. Raybon was making as an expert witness for the plaintiff. At $400 an hour, he had already billed about $11,000 and had another 30 hours to bill. She asked how he arrived in Charleston. A private plane was provided him by counsel for the plaintiff, he said.
Cohen pointed to at least six surgeries Ms. Cisson had undergone, the last being a partial mesh removal from Dr. Miklos in Atlanta, any one which could create scar tissue, she said.
She asked how many meshes does he still use today? About four or five different ones he said, including biologics, but not any with arms, the doctor responded.
On a re-cross exam, Jim Matthews asked the doctor about the complications of mesh erosion that he’s witnessed.
“Since last year I’ve become nervous it’s a ticking time bomb. Since January I’ve consulted on 12, removed five. A couple have gone to Dr. Miklos, I don’t know if it’s increased awareness. I have concerns about the arms, I think that’s the issue,” he said. #